Senior Maintenance and Utilities Technician at KYOWA KIRIN INC

Sanford, North Carolina, United States -

Full Time

Start Date

Immediate

Expiry Date

26 Jan, 26

Salary

48.0

Posted On

28 Oct, 25

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

GMP Compliance, Technical Troubleshooting, Preventive Maintenance, Corrective Repairs, Safety Adherence, Technical Support, Cross-Functional Collaboration, Mentoring, Documentation, Project Management, CMMS Proficiency, Communication Skills, Organizational Skills, Problem Solving, Adaptability, Interpersonal Skills

Industry

Pharmaceutical Manufacturing

Description

Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease. A Japan-based company, our goal is to translate science into smiles by delivering therapies where no adequate treatments currently exist, working from drug discovery to product development and commercialization. In North America, we are headquartered in Princeton, NJ, with offices in California, North Carolina, and Mississauga, Ontario. As the Senior Maintenance and Utilities Technician, this role ensures the reliable operation and maintenance of facility utilities and equipment at our biopharmaceutical manufacturing site by applying advanced expertise in GMP, regulatory compliance, and technical troubleshooting. You manage complex projects, mentor other technicians, and implement best practices to enhance team performance and efficiency. By proactively addressing maintenance needs and minimizing downtime, you maintain a clean, safe, and compliant production environment. As an individual contributor, you will take a compassionate and people-focused approach to your work. You will proactively collaborate with others to create a supportive and inclusive environment, always acting in line with the organization’s values. By using strong interpersonal skills, you will work effectively with diverse viewpoints, manage relationships thoughtfully, and make decisions that meet both individual and team needs. You will be accountable for delivering results, adapting to challenges, and helping achieve business goals. Additionally, you will take ownership of your tasks, act with initiative, and continuously seek opportunities to learn and grow. You will handle change with resilience and clarity, staying flexible in a fast-paced environment while keeping the needs of patients at the center of your efforts. This role reports into the Manager, Maintenance and Utilities Technical Skills, Knowledge, and Experience • Perform scheduled inspections, preventive maintenance, and corrective repairs on bioprocessing equipment such as bioreactors, centrifuges, and filtration units to ensure optimal performance and reliability. • Execute preventive and corrective maintenance on facility utilities, including boilers, chillers, air compressors, WFI water systems, HVAC systems, and other critical infrastructure as required. • Proactively diagnose complex equipment malfunctions, conduct timely repairs, and implement long-term solutions to prevent recurrence; escalate unresolved or critical issues to appropriate management or technical experts, providing clear documentation and recommendations. • Demonstrate a strong commitment to safety by adhering to all Environmental, Health, and Safety (EHS) policies and proactively identifying and mitigating potential hazards. • Provide technical support for the start-up, commissioning, and turnover of new systems throughout the site, ensuring seamless integration and compliance. • Maintain accurate and comprehensive maintenance records in compliance with GMP (Good Manufacturing Practices), FDA regulations, and audit requirements. • Collaborate closely with process engineers, quality assurance, manufacturing staff, and other cross-functional teams to resolve technical issues and support operational goals. • Mentor and provide technical guidance to other technicians and contractors, fostering knowledge sharing and professional development. • Document root causes of equipment failures and recommend effective, long-term solutions to enhance reliability and efficiency. • Plan and execute site shutdowns effectively, ensuring minimal disruption to operations while maintaining safety, compliance, and schedule adherence. Individual contributor, with responsibility to lead or work with cross-functional project teams. Education • High school diploma or equivalent, with a minimum demonstrated 3–5 years of relevant cGMP maintenance experience. • An associate or bachelor’s degree in a related field (such as engineering technology, mechanical engineering, or industrial maintenance) is preferred and may substitute for some experience. Experience • Minimum demonstrated 3–5 years of hands-on experience performing cGMP mechanical maintenance in both process and laboratory environments. • Minimum demonstrated 2–4 years of experience working within a GxP or other highly regulated environment. Technical Skills • Demonstrate proficiency in CMMS platforms such as D365 EAM, SAP PM, Maximo, or equivalent systems to manage calibration schedules, documentation, and asset history. • Collaborate effectively with internal stakeholders and service partners to deliver high-quality, customer-focused calibration and maintenance solutions. • Communicate clearly and professionally, both verbally and in writing, to ensure accurate documentation and effective coordination across teams. • Apply strong organizational skills and attention to detail to maintain data integrity, ensure compliance, and achieve audit readiness. • Demonstrated ability to develop, coordinate, and execute planned shutdowns, ensuring adherence to timelines, safety protocols, and operational requirements. Non-Technical Skills • Results-oriented and able to navigate ambiguity. • Set clear outcomes, track progress, follow through on commitments, and ensure actions lead to measurable results that advance organizational objectives. • Respond promptly, take accountability, and manage tasks efficiently. • Adapt to change with clarity, patience, and understanding, guiding teams through evolving challenges. • Exhibit strong organizational skills, attention to detail, and a solid work ethic while demonstrating cultural sensitivity and the ability to foster alignment in a global environment. • Communicate with care by actively listening and considering others' perspectives, fostering productive, engaging interactions, and managing relationships with kindness. • Embrace personal growth through continuous learning and knowledge sharing, maintaining a growth mindset. • Promote inclusive collaboration by respecting diverse perspectives and creating a welcoming work environment. • Contribute positively by recognizing achievements and encouraging a healthy work-life balance. • Collaborate with respect, integrity, and humility, prioritizing collective success over individual gain. • Resourceful and proactive, challenge the status quo, drive innovation, and develop creative solutions. • Apply an enterprise-wide, holistic mindset, working beyond siloed thinking to deliver cohesive, integrated solutions. Must be able to work in a regulated manufacturing environment, including construction/start-up phases, with appropriate PPE. Reasonable accommodation will be provided as required by law. This position is based on-site in Sanford, NC. Other standard company policies for flexible work arrangements do not apply to this role. This is not a hybrid or remote role. • Requires up to 5% domestic travel, based on business needs. • During construction and commissioning phases, the position follows a Monday–Friday day shift. During production runs, the schedule transitions to a 2-2-3 day shift as needed (12-hour day shift (7a.m.–7 p.m.) following a 2-2-3 rotation (two days on, two days off, three days on, alternating weekly)). Schedule provides every other weekend off • This position is designated as essential to site operations, as such the employee may be required to report to the facility or remain on-site during certain operational or emergency situations to ensure business continuity. • On-call availability may be required to support urgent operational needs. • Must be able to perform the physical requirements of the role, including occasionally lifting to 50 lbs, with or without reasonable accommodation. • Regularly works in environments with exposure to machinery, noise, and physical hazards. Appropriate personal protective equipment (PPE) is required at all times. The anticipated salary for this position will be $35 to $48 per/hour. The actual salary offered for this role at commencement of employment may vary based on several factors including but not limited to relevant experience, skill set, qualifications, education (including applicable licenses and certifications, job-based knowledge, location, and other business and organizational needs. The listed salary is just one component of the overall compensation package. At Kyowa Kirin North America we provide a comprehensive range of benefits including: 401K with company matching Discretionary Profit Sharing Annual Bonus Program (Sales Bonus for Sales Jobs) Generous PTO and Holiday Schedule which includes Summer and Winter Shut-Downs, Sick Days and, Volunteer Days Healthcare Benefits (Medical, Dental, Prescription Drugs and Vision) HSA & FSA Programs Well-Being and Work/Life Programs Long-Term Incentive Program (subject to job level and performance) Life & Disability Insurance Concierge Service Pet Insurance Tuition Assistance Employee Referral Awards The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market. KKNA and all of its employees have an obligation to act in accordance with the law and with integrity in all our operations and interactions It is the policy of Kyowa Kirin North America, Inc. to provide equal employment opportunity to all qualified persons without regard to race, religion, creed, color, pregnancy, sex, age, national origin, disability, genetic trait or predisposition, veteran status, marital status, sexual orientation or affection preference or citizenship status or any other category protected by law. When you apply to a job on this site, the personal data contained in your application will be collected and stored by Kyowa Kirin, Inc. (“Controller”), which is located at 510 Carnegie Center Dr. Princeton, NJ 08540 USA and can be contacted by emailing kkus.talentacquisition.8h@kyowakirin.com. Controller’s data protection officer can be contacted at usprivacyoffice@kyowakirin.com. Your personal data will be processed for the purposes of managing Controller’s recruitment related activities, which include setting up and conducting interviews and tests for applicants, evaluating and assessing the results thereto, and as is otherwise needed in the recruitment and hiring processes. Such processing is legally permissible under Art. 6(1)(f) of General Data Protection Regulation (EU) 2016/679 (“GDPR”) as necessary for the purposes of the legitimate interests pursued by the Controller, which are the solicitation, evaluation, and selection of applicants for employment. Your personal data will be shared with Greenhouse Software, Inc., a cloud services provider located in the United States of America and engaged by Controller to help manage its recruitment and hiring process on Controller’s behalf. Accordingly, if you are located outside of the United States, your personal data will be transferred to the United States once you submit it through this site. The transfer will be made using appropriate additional safeguards under the standard contractual clauses approved by regulators for transfers of personal data outside the European Union. Your personal data will be retained by Controller as long as Controller determines it is necessary to evaluate your application for employment. Under the GDPR, if you are located in the European Union, you have the right to request access to your personal data, to request that your personal data be rectified or erased, and to request that processing of your personal data be restricted. You also have the right to data portability, and to lodge a complaint with an EU supervisory authority. If you have any questions about our use of your data, you may contact us by email at usprivacyoffice@kyowakirin.com. Recruitment & Staffing Agencies Kyowa Kirin does not accept agency resumes unless contacted directly by internal Kyowa Kirin Talent Acquisition. Please do not forward resumes to Kyowa Kirin employees or any other company location; Kyowa Kirin is not responsible for any fees related to unsolicited resumes. #LI-SH1

Responsibilities

Ensure reliable operation and maintenance of facility utilities and equipment at the biopharmaceutical manufacturing site. Proactively address maintenance needs and minimize downtime to maintain a clean, safe, and compliant production environment.